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US7684873B2 - Implantable medical lead including a directional electrode and fixation elements along an interior surface - Google Patents

Implantable medical lead including a directional electrode and fixation elements along an interior surface Download PDF

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Publication number
US7684873B2
US7684873B2 US11/706,146 US70614607A US7684873B2 US 7684873 B2 US7684873 B2 US 7684873B2 US 70614607 A US70614607 A US 70614607A US 7684873 B2 US7684873 B2 US 7684873B2
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Prior art keywords
lead
surface portion
implantable medical
medical lead
electrode
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US11/706,146
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US20080103574A1 (en
Inventor
Martin T. Gerber
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Medtronic Inc
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Medtronic Inc
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Priority claimed from US11/591,279 external-priority patent/US8688238B2/en
Application filed by Medtronic Inc filed Critical Medtronic Inc
Priority to US11/706,146 priority Critical patent/US7684873B2/en
Assigned to MEDTRONIC, INC. reassignment MEDTRONIC, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GERBER, MARTIN T.
Priority to PCT/US2007/082819 priority patent/WO2008055097A2/fr
Priority to EP07863603A priority patent/EP2086629A2/fr
Priority to PCT/US2008/053543 priority patent/WO2008100841A1/fr
Publication of US20080103574A1 publication Critical patent/US20080103574A1/en
Application granted granted Critical
Publication of US7684873B2 publication Critical patent/US7684873B2/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0536—Preventing neurodegenerative response or inflammatory reaction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A61N1/0558—Anchoring or fixation means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0534—Electrodes for deep brain stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin

Definitions

  • the invention relates to medical device systems and, more particularly, to elongated members in medical device systems.
  • Electrical stimulation systems may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, dystonia, torticollis, epilepsy, pelvic floor disorders, gastroparesis, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles) or obesity.
  • An electrical stimulation system typically includes one or more implantable medical leads coupled to an electrical stimulator.
  • the implantable medical lead may be percutaneously or surgically implanted in a patient on a temporary or permanent basis such that at least one stimulation electrode is positioned proximate to a target stimulation site.
  • the target stimulation site may be, for example, a nerve or other tissue site, such as a spinal cord, pelvic nerve, pudendal nerve, stomach, bladder, or within a brain or other organ of a patient, or within a muscle or muscle group of a patient.
  • the one or more electrodes located proximate to the target stimulation site may deliver electrical stimulation therapy to the target stimulation site in the form electrical signal s.
  • Electrical stimulation of a sacral nerve may eliminate or reduce some pelvic floor disorders by influencing the behavior of the relevant structures, such as the bladder, sphincter and pelvic floor muscles.
  • Pelvic floor disorders include urinary incontinence, urinary urge/frequency, urinary retention, pelvic pain, bowel dysfunction, and male and female sexual dysfunction.
  • the organs involved in bladder, bowel, and sexual function receive much of their control via the second, third, and fourth sacral nerves, commonly referred to as S 2 , S 3 and S 4 respectively.
  • an implantable medical lead is implanted proximate to the sacral nerve(s).
  • Occipital nerves such as a lesser occipital nerve, greater occipital nerve or third occipital nerve, exit the spinal cord at the cervical region, extend upward and toward the sides of the head, and pass through muscle and fascia to the scalp. Pain caused by an occipital nerve, e.g. occipital neuralgia, may be treated by implanting a lead proximate to the occipital nerve to deliver stimulation therapy.
  • a stimulation lead In many electrical stimulation applications, it is desirable for a stimulation lead to resist migration following implantation. For example, it may be desirable for the electrodes disposed at a distal end of the implantable medical lead to remain proximate to a target stimulation site in order to provide adequate and reliable stimulation of the target stimulation site. In some applications, it may also be desirable for the electrodes to remain substantially fixed in order to maintain a minimum distance between the electrode and a nerve in order to help prevent inflammation to the nerve and in some cases, unintended nerve damage. Securing the implantable medical lead at the target stimulation site may minimize lead migration.
  • the invention is directed toward an implantable medical elongated member that includes one or more fixation elements along an interior surface of the elongated member, as well as a method for implanting the elongated member in a patient.
  • the elongated member is configured to be coupled to a medical device to deliver a therapy from the medical device to target therapy delivery site in a patient.
  • the therapy may be electrical stimulation, drug delivery, or both.
  • An “interior” surface of the elongated member is a portion of an outer surface of the elongated member that generally faces away from an epidermis layer of a patient (or a scalp of the patient, depending on the particular application of the elongated member) when implanted in subcutaneous tissue of the patient. Accordingly, an “exterior” side of the elongated member generally faces toward the epidermis of the patient when the elongated member is implanted in subcutaneous tissue of a patient.
  • the elongated member may be implanted so that the fixation elements face inward away from an integumentary layer of the patient (e.g., the epidermis, dermis, or scalp), rather than outward so as to avoid damage to the integumentary layer or irritation to the patient from engagement of a fixation member with the integumentary layer.
  • the elongated member is fixed at one or more points that are distributed about less than a full outer perimeter of the elongated member in order to minimize or eliminate points of stress between the one or more fixation elements and the epidermis or scalp of a patient.
  • At least a section of the exterior surface of the elongated member near a distal end of the elongated member is devoid of any fixation elements in order to help minimize or prevent stress points between the elongated member and an integumentary layer of the patient.
  • the exterior surface includes fixation elements that are sized to minimize any interference with the epidermis or scalp of the patient.
  • the elongated member is an implantable medical lead that is coupled to an implantable or external electrical stimulator, which is configured to deliver electrical stimulation therapy to a target stimulation site in a patient via the lead, and more specifically, via at least one electrode disposed adjacent to a distal end of a lead body of the lead.
  • the lead may be, for example, a cylindrical lead or a paddle lead.
  • the elongated member is a catheter configured to deliver a fluid, such as pharmaceutical agents, insulin, pain relieving agents, gene therapy agents, or the like from an implantable or external fluid reservoir and/or pump to a target tissue site in a patient.
  • the fixation element may be any suitable fixation element that helps substantially fix a position of the elongated member to (e.g., at or near) the target therapy delivery site, thereby reducing migration of the elongated member when the elongated member is implanted in a patient.
  • the invention is directed to an apparatus comprising an implantable medical elongated member configured to couple to a medical device to deliver a therapy from the medical device to a target therapy delivery site in a patient.
  • the elongated member extends between a proximal end and a distal end and defines an outer surface comprising a first outer surface portion, and a second outer surface portion extending around at least ten percent of an outer perimeter of the elongated member.
  • the apparatus further comprises a fixation element extending a distance from the first outer surface portion of the implantable medical elongated member.
  • a longitudinally-extending section of the second outer surface portion proximate to the distal end of the elongated member and extending around at least ten percent of the outer perimeter of the elongated member is substantially devoid of any fixation elements that extend the distance from second outer surface portion.
  • the invention is directed to a system including a medical device and an elongated member.
  • the implantable medical elongated member is configured to couple to the medical device to deliver a therapy from the medical device to a target therapy delivery site in a patient.
  • the elongated member extends between a proximal end and a distal end and defines an outer surface comprising a first outer surface portion, and a second outer surface portion extending around at least ten percent of an outer perimeter of the elongated member.
  • the apparatus further comprises a fixation element extending a distance from the first outer surface portion of the implantable medical elongated member.
  • a longitudinally-extending section of the second outer surface portion proximate to the distal end of the elongated member and extending around at least ten percent of the outer perimeter of the elongated member is devoid of any fixation elements that extend the distance from second outer surface portion.
  • the invention is directed toward an implantable medical lead comprising a lead body, one or more electrodes carried by the lead body, and one or more fixation elements extending from an outer surface of the lead body. At least a circumferential sub-section of the outer surface extending over at least ten degrees is substantially devoid of the fixation elements.
  • the invention is directed to method for implanting an elongated member in a patient.
  • the method comprises introducing the elongated member a body of a patient.
  • the elongated member extends between a proximal end and a distal end and defines an outer surface comprising a first outer surface portion and a second outer surface portion extending around at least ten percent of an outer perimeter of the elongated member.
  • the elongated member further comprises a fixation element extending a distance from the first outer surface portion of the implantable medical elongated member.
  • a longitudinally-extending section of the second outer surface portion proximate to the distal end of the elongated member and extending around at least ten percent of the outer perimeter of the elongated member is substantially devoid of any fixation elements that extend the distance from second outer surface portion.
  • the method further comprises orienting the elongated member so that the second outer surface portion faces a superficial direction and advancing the elongated member through the introducer to a target therapy delivery site to deploy the fixation member into tissue of the patient, wherein the fixation element engages with surrounding tissue to substantially fix a position of the elongated member proximate to the target therapy delivery site.
  • the invention is directed to an implantable medical lead comprising a lead body defining an outer surface comprising a first outer surface portion and a second outer surface portion extending around at least ten percent of an outer perimeter of the lead body.
  • the implantable medical lead further comprises a fixation element extending a distance from the first outer surface portion and at least one electrode coupled to the lead body.
  • a longitudinally-extending section of the second outer surface portion proximate to a distal end of the lead body is substantially devoid of any fixation elements that extend the distance from the second outer surface portion.
  • the longitudinally-extending section of the second outer surface portion is substantially devoid of any exposed electrodes.
  • the invention is directed toward an implantable medical lead comprising a substantially cylindrical lead body defining an outer surface comprising a first outer surface portion, and a second outer surface portion extending around at least ten percent of an outer perimeter of the lead body.
  • the implantable medical lead further comprises a fixation element extending a distance from the first outer surface portion and at least one electrode coupled to the lead body.
  • a longitudinally-extending section of the second outer surface portion proximate to a distal end of the lead body is substantially devoid of any fixation elements that extend the distance from the second outer surface portion.
  • the at least one electrode is configured to limit delivery of electrical stimulation to directions radially outward from the first outer surface portion.
  • the invention is directed to method for implanting an medical lead in a patient.
  • the method comprises introducing the medical lead into a body of the patient and advancing the medical lead to a target therapy delivery site within the body of the patient.
  • the medical lead defines an outer surface comprising a first outer surface portion and a second outer surface portion extending around at least approximately ten percent of an outer perimeter of the medical lead.
  • a longitudinally-extending section of the second outer surface portion proximate to a distal end of the medical lead is substantially devoid of any fixation elements that extend the distance from the second outer surface portion.
  • the medical lead further comprises at least one electrode coupled to the medical lead and a fixation element extending a distance from the first outer surface portion.
  • the second outer surface portion is substantially devoid of any exposed electrodes.
  • FIG. 1 illustrates the implantation of a therapy system, which includes an electrical stimulator coupled to an implantable medical lead, at a location proximate to an occipital nerve.
  • FIG. 2 is a block diagram illustrating various components of the electrical stimulator and implantable lead of the therapy system of FIG. 1 .
  • FIG. 3A is a perspective view of the implantable medical lead of FIG. 1 implanted in subcutaneous tissue.
  • FIG. 3B is a schematic cross-sectional view of the implantable medical lead of FIGS. 1-3A .
  • FIG. 3C is a schematic cross-sectional view of the introducer taken along line 3 C- 3 C in FIG. 1 .
  • FIGS. 4A-4B are schematic cross-sectional views of alternate embodiments of implantable medical leads including fixation elements along a first outer surface portion of the lead body.
  • FIGS. 5A-B illustrate alternate arrangements of fixation elements on a lead body.
  • FIG. 9 is a perspective view of a lead including fixation elements extending radially outward from a lead body at approximately 90° with respect to a first outer surface portion of the lead body.
  • FIGS. 10A and 10B are a perspective view and schematic cross-sectional view, respectively, of a lead including a fixation element extending around a first outer surface portion of a lead body.
  • FIG. 11 is a schematic cross-sectional view of a lead including a fixation element extending around less than a full first outer surface portion of a lead body.
  • FIG. 12A is a side view of a paddle lead including fixation elements along a first outer surface portion.
  • FIG. 12B is a schematic cross-sectional view of the lead body taken along line 12 B- 12 B in FIG. 12A .
  • FIGS. 13A and 13B are side views of alternate embodiments of a paddle lead including fixation elements along both the first outer surface portion and the second outer surface portion.
  • FIG. 14 is a flow diagram illustrating one example method for implanting a lead including fixation members along a first outer surface portion in accordance with an embodiment of the present invention.
  • FIG. 15A is a perspective view of one embodiment of a lead including directional electrodes and fixation elements along a first outer surface portion of a lead body.
  • FIG. 15B is a schematic cross-sectional view of the lead of FIG. 15A taken along line 15 B- 15 B in FIG. 15A .
  • FIG. 15C a cross-sectional view of another embodiment of the lead shown in FIG. 15B , which includes an electrically insulating mask covering at least a portion of an electrode.
  • FIG. 16A is a perspective view of a lead and a sheath disposed over full ring electrodes to electrically insulate a subsection of the electrodes.
  • FIG. 16B is a schematic cross-sectional view of the lead of FIG. 16A taken along line 16 B- 16 B in FIG. 16A .
  • FIG. 17 is a schematic cross-sectional view of another embodiment of a lead, which includes an electrode with an electrically conductive section along an entire first outer surface portion of the lead body.
  • FIG. 18 is a perspective view of an embodiment of a lead including segmented electrodes, as well as fixation elements along a first outer surface portion of a lead body.
  • FIG. 19A is a perspective view of another embodiment of a lead including directional electrodes and fixation elements along a first outer surface portion of a lead body.
  • FIG. 19B is a schematic cross-sectional view of the lead of FIG. 19A taken along line 18 B- 18 B in FIG. 19A .
  • the present invention relates to an implantable medical elongated member including one or more fixation elements disposed about an outer surface of the elongated member in an arrangement that minimizes or eliminates points of stress between the fixation elements and an integumentary layer (e.g., an epidermis layer, dermis or scalp) of a patient.
  • the elongated member may include fixation elements that radially extend from less than a full outer circumference of a lead body or fixation elements disposed along one outer surface portion of the elongated member.
  • the elongated member may be implanted so that the fixation elements do not interfere with the epidermis, dermis, or scalp of the patient.
  • the elongated member may be implanted such that the fixation elements may face away from the epidermis, dermis, or scalp of the patient.
  • the elongated member is configured to be coupled to a medical device to deliver a therapy from the medical device to target tissue in a patient.
  • the elongated member may be a stimulation lead or a lead extension that is used to deliver electrical stimulation to a target stimulation site and/or sense parameters (e.g., blood pressure, temperature or electrical activity) of a patient.
  • the elongated member may be a catheter that is placed to deliver a fluid, such as pharmaceutical agents, insulin, pain relieving agents, gene therapy agents or the like from a fluid delivery device (e.g., a fluid reservoir and/or pump) to a target tissue site in a patient.
  • a fluid delivery device e.g., a fluid reservoir and/or pump
  • the invention is applicable to any configuration or type of implantable elongated member that is used to deliver therapy to a site in a patient. For purposes of illustration, however, the disclosure will refer to a neurostimulation lead.
  • FIG. 1 a schematic perspective view of a therapy system 10 , which includes an electrical stimulator 12 coupled to implantable medical lead 14 .
  • Lead 14 is aligned to be introduced into introducer needle 16 , which is positioned proximate to target stimulation site 18 of patient 20 .
  • lead 14 is aligned to be implanted and anchored or fixated with fixation elements proximate to target stimulation site 18 within patient 20 for stimulation of one or more occipital nerves.
  • target stimulation site 18 is proximate to at least one of lesser occipital nerve 22 , greater occipital nerve 24 or third occipital nerve 26 .
  • lead 14 may be positioned proximate to one or more other peripheral nerves proximate to occipital nerves 22 , 24 , and 26 of patient 20 , such as nerves branching from occipital nerves 22 , 24 or 26 .
  • therapy system 10 may be used to provide stimulation therapy to any other suitable nerves within patient 20 , such as, but not limited to, trigeminal nerves, branches of trigeminal nerves or nerves within a brain, stomach or spinal cord of patient 20 .
  • electrical stimulator 12 is a neurostimulator that is either implantable or external.
  • neurostimulator 12 may be subcutaneously implanted in the body of a patient (e.g., in a chest cavity, lower back, lower abdomen, or buttocks of patient 20 ).
  • Neurostimulator 12 provides a programmable stimulation signal (e.g., in the form of electrical pulses or substantially continuous-time signals) that is delivered to target stimulation site 18 by implantable medical lead 14 , and more particularly, via one or more stimulation electrodes 28 carried by lead 14 .
  • programmable stimulation signal e.g., in the form of electrical pulses or substantially continuous-time signals
  • neurostimulator 12 may be coupled to two or more leads, e.g., for bilateral or multi-lateral stimulation.
  • Stimulation of occipital nerves 22 , 24 , and 26 may help alleviate pain associated with, for example, chronic migraines, cervicogenic headaches, occipital neuralgia or trigeminal neuralgia.
  • Neurostimulator 12 may also be referred to as a pulse generator.
  • lead 14 may also carry one or more sense electrodes to permit neurostimulator 12 to sense electrical signals from target stimulation site 18 .
  • Proximal end 14 A of lead 14 may be both electrically and mechanically coupled to connector 13 of neurostimulator 12 either directly or indirectly (e.g., via a lead extension).
  • conductors disposed within a lead body of lead 14 electrically connect stimulation electrodes 28 (and sense electrodes, if present) located adjacent to distal end 14 B of lead 14 to neurostimulator 12 .
  • lead 14 further includes one or more one fixation elements (not shown in FIG. 1 ) extending from an interior portion of an outer surface of lead 14 to help substantially fix lead 14 proximate to target stimulation site 18 .
  • an interior portion of the outer surface of lead 14 faces away from scalp 30 of patient 20 .
  • an exterior portion of the outer surface of lead i.e., a portion that faces scalp 30 when lead 14 is implanted in patient 20
  • implantation of lead 14 may involve the subcutaneous placement of lead 14 transversely across one or more occipital nerves 22 , 24 , and/or 26 that are causing patient 20 to experience pain.
  • patient 30 may be placed in a lateral position or in a prone position during implantation of lead 14 .
  • a clinician may palpate the area of pain.
  • a screening lead may be used prior to implanting lead 14 to develop optimal stimulation parameters (e.g., various electrode combinations, amplitude, pulse width or rate).
  • a vertical skin incision 33 approximately two centimeters in length is made in the neck of patient 20 lateral to the midline of the spine at the level of the C1 vertebra. Fluoroscopy may be used to identify the location of the C1 vertebra. Typically, local anesthetic is used during the implantation procedure. The length of vertical skin incision 33 may vary depending on the particular patient. At this location, the patient's skin and muscle are separated by a band of connective tissue referred to as fascia.
  • Introducer needle 16 which may be a Tuohy needle, is introduced into the subcutaneous tissue, superficial to the fascia and muscle layer but below the skin.
  • introducer needle 16 may be manually curved by the clinician to conform to the contour of the body of patient 20 proximate to the peripheral nerve, and in the embodiment shown in FIG. 1 , the clinician may conform introducer needle 16 to the contour of the neck of patient 20 .
  • Occipital nerves 22 , 24 , and 26 are located within the cervical musculature and overlying fascia, and as a result, introducer needle 16 , and eventually lead 14 , are inserted superior to occipital nerves 22 , 24 , and 26 . That is, in one embodiment, introducer needle 16 is introduced into the fascia layer of patient 20 such that introducer needle 16 is between the skin of patient 20 and the occipital nerve 22 , 24 , and/or 26 to be stimulated.
  • Introducer needle 16 may be guided transversely from incision 33 across the midline of the spine of patient 16 . Fluoroscopic observation may aid the clinician in identifying the trunk of the occipital nerve.
  • a needle stylet may be removed from the introducer needle, if introducer needle 16 includes a stylet.
  • Lead 14 may then be advanced through introducer needle 16 and positioned to allow stimulation of the lesser occipital nerve 22 , greater occipital nerve 24 , third occipital nerve 26 , and/or other peripheral nerves proximate to an occipital nerve.
  • the position of lead 14 may be verified via fluoroscopy or another suitable technique.
  • the clinician may confirm that the electrodes proximate to distal end 14 A of lead 14 are properly placed with respect to the particular occipital nerve.
  • the clinician may provide electrical signals to the electrodes and patient 30 may provide feedback relating to the paresthesia coverage.
  • introducer needle 16 may be removed (either before or after confirming the placement of the electrodes). As described below, in one embodiment, upon removal of introducer needle 16 , the one or more fixation elements of lead 14 engage with surrounding tissue to substantially fix a position of lead 14 proximate to target stimulation site 18 . In another embodiment, the one or more fixation elements of lead 14 adhere to surrounding tissue to substantially fix a position of lead 14 .
  • Accurate lead placement may affect the success of occipital nerve stimulation, as well as any other nerve stimulation application of therapy system 10 . If lead 14 is located too deep, i.e. anterior, in the subcutaneous tissue, patient 20 may experience muscle contractions, grabbing sensations, or burning. Such problems may additionally occur if lead 14 migrates after implantation. Furthermore, due to the location of implanted lead 14 on the back of the neck of patient 20 , lead 14 may be subjected to pulling and stretching that may increase the chances of lead migration. For these reasons, fixating lead 14 may be advantageous.
  • therapy system 10 is useful in other neurostimulation applications.
  • target stimulation site 18 may be a location proximate to other nerves, organs, muscles, muscle groups or other tissue sites in patient 20 , which may be selected based on, for example, a therapy program selected for a particular patient 20 .
  • therapy system 10 may be used to deliver neurostimulation therapy to a sacral nerve, a pudendal nerve, a perineal nerve or other areas of the nervous system, in which cases, lead 14 would be implanted and substantially fixed proximate to the respective nerve.
  • lead 14 may be positioned for temporary or chronic spinal cord stimulation for the treatment of pain, for peripheral neuropathy or post-operative pain mitigation, ilioinguinal nerve stimulation, intercostal nerve stimulation, gastric stimulation for the treatment of gastric mobility disorders and obesity, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles), for mitigation of other peripheral and localized pain (e.g., leg pain or back pain), or for deep brain stimulation to treat movement disorders and other neurological disorders.
  • FES functional electrical stimulation
  • patient 20 and target stimulation site 18 of FIG. 1 are referenced throughout the remainder of the disclosure for purposes of illustration, a neurostimulation lead 14 in accordance with the invention may be adapted for use in a variety of electrical stimulation applications.
  • Treatment system 10 may also include clinician programmer 32 and patient programmer 34 .
  • Clinician programmer 32 may be a handheld computing device that permits a clinician to program neurostimulation therapy for patient 20 , e.g., using input keys and a display.
  • the clinician may specify neurostimulation parameters for use in delivery of neurostimulation therapy.
  • Clinician programmer 32 supports telemetry (e.g., radio frequency (RF) telemetry) with neurostimulator 12 to download neurostimulation parameters and, optionally, upload operational or physiological data stored by neurostimulator 12 . In this manner, the clinician may periodically interrogate neurostimulator 12 to evaluate efficacy and, if necessary, modify the stimulation parameters.
  • RF radio frequency
  • patient programmer 34 may be a handheld computing device.
  • Patient programmer 34 may also include a display and input keys to allow patient 20 to interact with patient programmer 34 and neurostimulator 12 .
  • patient programmer 34 provides patient 20 with an interface for control of neurostimulation therapy by neurostimulator 12 .
  • patient 20 may use patient programmer 34 to start, stop or adjust neurostimulation therapy.
  • patient programmer 34 may permit patient 20 to adjust stimulation parameters such as duration, amplitude, pulse width and pulse rate, within an adjustment range specified by the clinician via clinician programmer 34 , or select from a library of stored stimulation therapy programs.
  • Neurostimulator 12 , clinician programmer 32 , and patient programmer 34 may communicate via cables or a wireless communication, as shown in FIG. 1 .
  • Clinician programmer 32 and patient programmer 34 may, for example, communicate via wireless communication with neurostimulator 12 using RF telemetry techniques known in the art.
  • Clinician programmer 32 and patient programmer 34 also may communicate with each other using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared communication, e.g., according to the IrDA standard, or other standard or proprietary telemetry protocols.
  • FIG. 2 is a block diagram illustrating various components of neurostimulator 12 and an implantable medical lead 14 .
  • Neurostimulator 12 includes therapy delivery module 40 , processor 42 , memory 44 , telemetry module 46 , and power source 47 .
  • neurostimulator 12 may also include a sensing circuit (not shown in FIG. 2 ).
  • Implantable medical lead 14 includes lead body 48 extending between proximal end 48 A and distal end 48 B.
  • lead body 48 is cylindrical and defines an outer surface including a first portion 49 A, which is facing away from the plane of the image of FIG. 2 .
  • the outer surface of lead body 48 further defines a second portion 49 B (not shown in FIG. 2 ) that faces into the plane of the image of FIG. 2 .
  • lead body 48 may be paddle-shaped (i.e., a “paddle” lead), in which case lead body 48 would define two opposing surfaces, as shown in FIG. 11 with respect to lead 142 .
  • Electrodes 28 A, 28 B, 28 C, and 28 D are disposed on lead body 48 adjacent to distal end 48 B of lead body 48 .
  • electrodes 28 may be ring electrodes.
  • electrodes 28 may be segmented or partial ring electrodes, each of which extends along an arc less than 360 degrees (°) (e.g., 90-120 degrees) around the circumference of lead body 48 .
  • the configuration, type, and number of electrodes 28 illustrated in FIG. 2 are merely exemplary.
  • electrodes 28 may extend along one side of lead body 48 . Electrodes 28 extending around a portion of the circumference of lead body 48 or along one side of a paddle lead may be useful for providing an electrical stimulation field in a particular direction/targeting a particular therapy delivery site. For example, in the electrical stimulation application shown in FIG. 1 , electrodes 28 may be disposed along lead body 48 such that the electrodes face toward occipital nerves 22 , 24 , and/or 26 , or otherwise away from scalp 30 . This may be an efficient use of stimulation because electrical stimulation of scalp 30 may not provide any or very minimal useful therapy to patient 20 .
  • segmented or partial ring electrodes 28 may also reduce the overall power delivered to electrodes 28 by neurostimulator 12 because of the efficient delivery of stimulation to occipital nerves 22 , 24 , and/or 26 (or other target stimulation site) by eliminating or minimizing the delivery of stimulation to unwanted or unnecessary regions within patient 20 .
  • lead 14 may include one or more orientation markers 45 proximate to proximal end 14 A that indicate the relative location of electrodes 28 .
  • Orientation marker 45 may be a printed marking on lead body 48 , an indentation in lead body 48 , a radiographic marker, or another type of marker that is visible or otherwise detectable (e.g., detectable by a radiographic device) by a clinician.
  • Orientation marker 45 may help a clinician properly orient lead 14 such that electrodes 28 face the desired direction (e.g., toward occipital nerves 22 , 24 , and/or 26 ) within patient 20 .
  • orientation marker 45 may also extend around the same portion of the circumference of lead body 48 or along the side of the paddle lead as electrodes 28 . In this way, orientation marker 45 faces the same direction as electrodes, thus indicating the orientation of electrodes 28 to the clinician. When the clinician implants lead 14 in patient 20 , orientation marker 45 may remain visible to the clinician.
  • Neurostimulator 12 delivers stimulation therapy via electrodes 28 of lead 14 .
  • electrodes 28 are electrically coupled to a therapy delivery module 40 of neurostimulator 12 via conductors within lead body 48 .
  • an implantable signal generator or other stimulation circuitry within therapy delivery module 40 delivers electrical signals (e.g., pulses or substantially continuous-time signals, such as sinusoidal signals) to targets stimulation site 18 ( FIG. 1A ) via at least some of electrodes 28 under the control of a processor 42 .
  • the implantable signal generator may be coupled to power source 47 .
  • Power source 47 may take the form of a small, rechargeable or non-rechargeable battery, or an inductive power interface that transcutaneously receives inductively coupled energy. In the case of a rechargeable battery, power source 47 similarly may include an inductive power interface for transcutaneous transfer of recharge power.
  • the stimulation energy generated by therapy delivery module 40 may be formulated as neurostimulation energy, e.g., for treatment of any of a variety of neurological disorders, or disorders influenced by patient neurological response.
  • the signals may be delivered from therapy delivery module 40 to electrodes 28 via a switch matrix and conductors carried by lead 14 and electrically coupled to respective electrodes 28 .
  • Processor 42 may include a microprocessor, a controller, a DSP, an ASIC, an FPGA, discrete logic circuitry, or the like.
  • Processor 42 controls the implantable signal generator within therapy delivery module 40 to deliver neurostimulation therapy according to selected stimulation parameters. Specifically, processor 42 controls therapy delivery module 40 to deliver electrical signal s with selected amplitudes, pulse widths (if applicable), and rates specified by the programs.
  • processor 42 may also control therapy delivery module 40 to deliver the neurostimulation signals via selected subsets of electrodes 28 with selected polarities. For example, electrodes 28 may be combined in various bipolar or multi-polar combinations to deliver stimulation energy to selected sites, such as nerve sites adjacent the spinal column, pelvic floor nerve sites, or cranial nerve sites.
  • Processor 42 may also control therapy delivery module 40 to deliver each stimulation signal according to a different program, thereby interleaving programs to simultaneously treat different symptoms or provide a combined therapeutic effect.
  • neurostimulator 12 may be configured to deliver neurostimulation therapy to treat other symptoms such as pain or incontinence.
  • Memory 44 of neurostimulator 12 may include any volatile or non-volatile media, such as a RAM, ROM, NVRAM, EEPROM, flash memory, and the like.
  • memory 44 of neurostimulator 12 may store multiple sets of stimulation parameters that are available to be selected by patient 20 via patient programmer 34 ( FIG. 1 ) or a clinician via clinician programmer 32 ( FIG. 1 ) for delivery of neurostimulation therapy.
  • memory 44 may store stimulation parameters transmitted by clinician programmer 32 ( FIG. 1 ).
  • Memory 44 also stores program instructions that, when executed by processor 42 , cause neurostimulator 12 to deliver neurostimulation therapy.
  • computer-readable media storing instructions may be provided to cause processor 42 to provide functionality as described herein.
  • processor 42 controls telemetry module 46 to exchange information with an external programmer, such as clinician programmer 32 and/or patient programmer 34 ( FIG. 1 ), by wireless telemetry.
  • telemetry module 46 supports wireless communication with one or more wireless sensors that sense physiological signals and transmit the signals to neurostimulator 12 .
  • migration of lead 14 following implantation may be undesirable, and may have detrimental effects on the quality of therapy delivered to a patient 20 .
  • migration of lead 14 may cause displacement of electrodes 28 carried adjacent to distal end 14 B of lead 14 with respect to target stimulation site 18 .
  • the electrodes may not be properly positioned to deliver therapy to target stimulation site 18 , resulting in reduced electrical coupling, and possibly undermining therapeutic efficacy of the neurostimulation therapy from system 10 .
  • Substantially fixing lead 14 to surrounding tissue may help prevent lead 14 from migrating from target stimulation site 18 following implantation, which may ultimately help avoid harmful effects that may result from a migrating lead 14 .
  • it may be desirable to fix lead 14 such that electrodes 28 remain proximate to target stimulation site 18 ( FIG. 1 ) in some situations, it may also be desirable to minimize discomfort to patient 20 from lead 14 .
  • lead 14 when lead 14 is implanted in a dermis or subcutaneous tissue of patient 20 ( FIG. 1 ), such as in the occipital nerve stimulation application shown in FIG. 1 , patient 20 may be more aware of lead 14 due to the location of lead 14 near an epidermis, scalp 30 or another integumentary layer of patient 20 .
  • lead 14 includes fixation elements 50 , 52 , and 54 (not shown in FIG. 3A ) along a first portion 49 A of outer surface 49 of lead body 48 to minimize migration of lead 14 and substantially fix a position of electrodes 28 proximate to target stimulation site 18 .
  • fixation elements 50 , 52 , and 54 (not shown in FIG. 3A ) along a first portion 49 A of outer surface 49 of lead body 48 to minimize migration of lead 14 and substantially fix a position of electrodes 28 proximate to target stimulation site 18 .
  • lead body 48 may be oriented such that first portion 49 A (“first outer surface portion”) of outer surface 49 generally faces away from the scalp 30 of patient and in an inward, deep direction and a majority of second portion 49 B (“second outer surface portion”) (shown in FIG. 3B ) faces outward in a superficial direction.
  • first portion 49 A of outer surface 49 may also be referred to as an “interior surface” of lead body 48 and second portion 49 B may also be referred to as an “exterior surface” of lead body 48 .
  • the caregiver will take note of the interior and exterior surfaces 49 A, 49 B of lead body 48 and appropriately position lead 14 so that the interior and exterior surfaces face inward and outward, respectively.
  • Fixation elements 50 , 52 , and 54 engage with surrounding tissue at target stimulation site 18 to fix a position of lead 14 .
  • fixation elements 50 and 54 extend substantially parallel to scalp 30 and fixation element 52 extends away from scalp 30 .
  • second portion 49 B of outer surface 49 of lead body 48 is devoid of any fixation elements.
  • lead 14 does not include any fixation elements that may extend into scalp 30 , and possibly protrude through scalp 30 , thereby resulting in an implantable medical lead 14 that is more comfortable to patient 20 and reduces the possibility of erosion or damage to subcutaneous tissue.
  • fixation elements 50 , 52 , and 54 may include any suitable number of fixation elements 50 , 52 , and 54 . Furthermore, fixation elements 50 , 52 , and 54 need not be protrusions that extend from lead 14 .
  • Fixation elements 50 , 52 , and 54 may be any suitable actively or passively deployed fixation element that helps prevent migration of lead 14 when lead 14 is implanted in patient 20 , such as, but not limited to, one or more tines, barbs, hooks, wire-like elements, adhesives (e.g., surgical adhesives), balloon-like fixation elements, pinning fixation elements, collapsible or expandable fixation structures, and so forth.
  • Fixation elements 50 , 52 , and 54 may be composed of any suitable biocompatible material, including, but not limited to, polymers, titanium, stainless steel, Nitinol, other shape memory materials, hydrogel or combinations thereof.
  • Fixation elements 50 , 52 , and 54 may be any suitable size, which may depend on the particular application of lead 14 . In particular, it may be desirable to select the size of or otherwise configure fixation elements 50 , 52 , and 54 to fix lead 14 to a particular region of the patient proximate to the target stimulation site (e.g., a peripheral nerve stimulation site), which may involve selecting the size of fixation elements 50 , 52 , and 54 to accommodate the specific anatomical configuration of a region of the patient proximate to the peripheral nerve.
  • the target stimulation site e.g., a peripheral nerve stimulation site
  • fixation elements 50 , 54 , and 54 may not be attached directly to lead 14 , but may be carried by another apparatus that is attached to the elongated member, such as a sleeve or mounting band.
  • a mounting band is described in commonly-assigned U.S. Pat. No. 6,999,819, entitled “IMPLANTABLE MEDICAL ELECTRICAL STIMULATION LEAD FIXATION METHOD AND APPARATUS” and issued on Feb. 14, 2006, which is hereby incorporated by reference in its entirety.
  • hydrogel fixation elements examples include those described in commonly assigned U.S. Patent Application Publication No. 2006/0095077, entitled “EXPANDABLE FIXATION STRUCTURES and filed on Oct. 29, 2004, U.S. Patent Application Publication No. 2006/0095078, entitled “EXPANDABLE FIXATION MECHANISM” and filed on Oct. 29, 2004, and U.S. patent application Ser. No. 11/591,174 by Martin T. Gerber, entitled “IMPLANTABLE MEDICAL ELONGATED MEMBER INCLUDING EXPANDABLE FIXATION MEMBER” and filed on Oct. 31, 2006.
  • fixation elements may include wire-like fixation elements as described in commonly assigned U.S. Patent Application Publication No. 2005/0096718, entitled “IMPLANTABLE STIMULATION LEAD WITH FIXATION MECHANISM” and filed on Oct. 31, 2003 and commonly-assigned U.S. patent application Ser. No. 11/591,282 by Martin T. Gerber, entitled “IMPLANTABLE STIMULATION LEAD INCLUDING WIRE-LIKE FIXATION ELEMENTS” and filed on Oct. 31, 2006.
  • An example of tine fixation elements is described in U.S. Pat. No. 6,999,819, entitled “IMPLANTABLE MEDICAL ELECTRICAL STIMULATION LEAD FIXATION METHOD AND APPARATUS” and filed on Nov. 9, 2001.
  • a suitable lead including a tissue-receiving cavity is described in commonly-assigned U.S. patent application Ser. No. 11/591,294 by Martin T. Gerber, entitled “IMPLANTABLE MEDICAL ELONGATED MEMBER INCLUDING A TISSUE RECEIVING CAVITY” and filed on Oct. 31, 2006.
  • An example of a suitable in situ formed fixation element is described in commonly-assigned U.S. patent application Ser. No. 11/591,433 by Martin T. Gerber, entitled “IMPLANTABLE MEDICAL ELONGATED MEMBER WITH IN SITU FORMED FIXATION ELEMENT” and filed on Oct. 31, 2006.
  • An example of suitable balloon-like fixation elements are described in commonly-assigned U.S. patent application Ser. No. 11/591,447 by Martin T. Gerber, entitled, “IMPLANTABLE STIMULATION LEAD INCLUDING BALLOON FIXATION ELEMENT” and filed on Oct. 31, 2006.
  • FIG. 3A illustrates a schematic cross-sectional view of skin 61 of patient 20 , which includes epidermis 62 , dermis 64 , and subcutaneous tissue 66 , as well as a portion of a nerve 68 .
  • FIG. 3A further shows a perspective view of implantable medical lead 14 of FIGS. 1 and 2 implanted in a subcutaneous tissue 66 proximate to nerve 68 .
  • FIG. 3B illustrates a schematic cross-sectional view of lead 14 taken along line 3 B- 3 B in FIG. 3A .
  • Distal end 48 B of lead body 48 is shown in FIG. 3A .
  • Proximal end 48 A of lead body 48 which contains contacts (not shown in FIGS. 3A and 3B ) to electrically couple lead 14 (and in particular, electrodes 28 ) to a lead extension or a neurostimulator (e.g., neurostimulator 12 in FIG. 1 ).
  • Skin 61 and nerve 68 are general representations of a region of patient 20 and are shown to aid in the description of the invention, and thus, are not necessarily specific to a specific nerve of patient 20 , nor drawn to any particular scale.
  • lead 14 may be partially implanted within patient 20 and lead 14 (or a lead extension to which proximal end 14 A (shown in FIG. 1 ) is coupled) may extend through epidermis layer 62 via a percutaneous port.
  • lead body 48 defines outer surface 49 , which includes first (“interior”) outer surface portion 49 A and second (“exterior”) outer surface portion 49 B, which are demarcated by line 69 in FIG. 3A .
  • first outer surface portion 49 A and second outer surface portion 49 B do not overlap and have center points 70 and 72 that are generally opposite each other. Center points 70 and 72 are shown in FIG. 3B and referred to herein as reference points to aid in the description of the invention.
  • Fixation elements 50 , 52 , and 54 (shown in FIG. 3B ) are distributed about less than a full outer perimeter of lead body 48 because first outer surface portion 49 A extends around less than a full outer perimeter of lead body 48 .
  • the outer perimeter of lead body 48 is the outer circumference of lead body 48 . In embodiments in which a lead includes a noncircular cross-section, the outer perimeter of the lead body is defined by the outermost edge of a cross-section of the lead body.
  • first outer surface portion 49 A has a larger size (i.e. measured in terms of surface area) than second outer surface portion 49 B.
  • second outer surface portion 49 B extends around less than or equal to about 50 percent (%) of the outer perimeter of lead body 48 .
  • second outer surface portion 49 B extends around at least 10% of the outer perimeter of lead body 48
  • second outer surface portion 49 A extends around about 50% to about 90% of the outer perimeter of lead body 48 .
  • first outer surface portion 49 A extends around approximately 75% of the outer perimeter of lead body 48 .
  • fixation elements 50 , 52 , and 54 are distributed about approximately 75% of the outer perimeter of lead body 48 .
  • first and second portions 49 A and 49 B may be the same size.
  • demarcation line 69 may extend through a center of lead body 48 , such that first and second outer surface portions 49 A and 49 B each define a half of lead body 48 .
  • demarcation line 69 may be moved toward center point 70 of first portion 49 A to define a second portion 49 B that is a greater (i.e., has a greater surface area) than first portion 49 A.
  • first outer surface portion 49 A extends around approximately 75% of the outer perimeter of lead body 48 , or alternatively, extends over about 270°.
  • first and second outer surface portions 49 A and 49 B lead 14 may be oriented and implanted in patient such that first outer surface portion 49 A (particularly center point 70 ) generally faces a deep direction 67 A (i.e., faces away from epidermis 62 ), while a majority of second outer surface portion 49 B (particularly center point 72 ) faces a superficial direction 67 B (i.e., faces toward epidermis 62 ).
  • first outer surface portion 49 A particularly center point 70
  • second outer surface portion 49 B particularly center point 72
  • a superficial direction 67 B i.e., faces toward epidermis 62
  • first outer surface portion 49 A neither faces toward nor away from epidermis 62 , but rather faces a direction 63 (shown in FIG. 3B ) that is generally parallel to epidermis 62 . Only a small percentage of second outer surface portion 49 B faces direction 63 , and thus, it can be said that the “majority” of second outer surface portion 49 B faces a superficial direction.
  • Lead 14 may include a visible marker 65 (shown in FIG. 2 in phantom) on the proximal end 48 A of lead body 48 .
  • Visible marker 65 may provide a reference point for a clinician during implantation of lead 14 in patient 20 .
  • the clinician may use visible marker 65 to orient lead 14 such that first outer surface portion 49 A faces a deep direction when lead 14 is implanted in patient 20 .
  • Visible marker 65 may be a printed marking on lead body 48 , an indentation in lead body 48 , a radiographic marker, or another type of marker that is visible or otherwise detectable (e.g., detectable by a radiographic device) by a clinician.
  • visible marker 65 is shown in phantom because visible marker 65 is located on second outer surface portion 49 B of lead body 48 , which is facing into the plane of the image of FIG. 2 .
  • visible marker 65 may be on first outer surface portion 49 A.
  • visible marker 65 may be any suitable configuration (e.g., another shape, size, etc.).
  • introducer 16 may have orientation marks to properly orient fixation elements 50 , 52 , and 54 of lead 14 with respect to epidermis 62 of patient 20 .
  • proximal end 16 A of introducer 16 may include printed markings for aligning with visible marker 65 of lead 14 to orient lead 14 such that first outer surface portion 49 A faces away from epidermis 62 when lead 14 is implanted in patient 20 .
  • visible marker 65 and orientation marker 45 may overlap and may effectively be a single marker.
  • FIG. 3C is a schematic cross-sectional view of introducer 16 taken along line 3 C- 3 C in FIG. 1 .
  • introducer 16 may be keyed to receive lead 14 in a certain orientation.
  • introducer 16 defines lumen 79 for receiving lead body 48 , where lumen 79 defines channels 80 A-C that are sized and otherwise configured to receive fixation elements 50 , 52 , and 54 , respectively, so that lead 14 may be introduced into introducer 16 in a limited number of orientations.
  • introducer 16 may be used to force proper orientation of lead 14 with respect to epidermis 62 .
  • Introducer 16 may be properly oriented with respect to epidermis 62 via any suitable means, such as, for example, visible or radiographic marker 81 on introducer 16 .
  • the clinician when the clinician is introducing introducer 16 into patient 20 , the clinician may orient introducer 16 such that visible or radiographic marker 81 is facing the clinician or facing a particular direction in order to properly orient channels 80 A-C with respect to epidermis 62 .
  • channels 80 A-C defined by lumen 79 of introducer 16 may help minimize the overall diameter of introducer 16 , which may help minimize the invasiveness of an implantation procedure.
  • a keyed stylet may be used to guide lead 14 into an orientation that results in fixation elements 50 , 52 , and 54 facing away from epidermis 62 .
  • a stylet may be keyed to receive lead 14 in one orientation.
  • At least a longitudinally-extending section (i.e., extending in the direction between proximal end 48 A and distal end 48 B of lead body 48 ) of second outer surface portion 49 B near electrodes 28 is devoid of any fixation elements or of any fixation elements that may extend into epidermis layer 62 when lead 14 is implanted in subcutaneous tissue 66 .
  • the entire second outer surface portion 49 B is devoid of any fixation elements.
  • second outer surface portion 49 B may include fixation elements sized to engage with subcutaneous tissue 66 , but not epidermis 62 or dermis 64 , or fixation elements to engage with dermis 64 , but not epidermis 62 .
  • a portion of second outer surface portion 49 B other than the portion proximate to electrodes 28 may include fixation members that are the same size or greater than fixation elements 50 , 52 , and 54 .
  • Fixation elements 50 , 52 , and 54 are angled toward proximal end 48 A of lead body 48 , which may help distal end 48 B of lead body 48 resist the pulling force from proximal end 48 A. However, in some applications, it may also be desirable for lead 14 to resist pulling forces from distal end 48 B. Accordingly, the invention contemplates configurations of fixation elements 50 , 52 , and 54 that are angled both toward and away from proximal end 48 A of lead body 48 (e.g., as shown in FIG. 8 ).
  • Fixation elements 50 , 52 , and 54 radially extend from lead body 48 at an acute angle with respect to first portion 49 A. However, in other embodiments, fixation elements 50 , 52 , and 54 radially extend from lead body 48 at a 90° angle (e.g., as shown with respect to fixation elements 126 , 128 , and 130 in FIG. 9 ). Extending from lead body 48 at an acute angle enables fixation elements 50 , 52 , and 54 to engage with surrounding tissue to prevent both axial and radial movement of lead body 48 .
  • FIG. 3B is a schematic cross-sectional view of lead 14 taken along line 3 B- 3 B in FIG. 3A .
  • Lead body 48 carries a plurality of conductors 74 (shown in FIG. 3B as a single conductive center of lead body 48 for clarity of illustration) for electrically coupling electrodes 28 ( FIG. 3A ) to therapy delivery module 40 of neurostimulator 12 ( FIG. 2 ).
  • a separate conductor electrically couples each electrode 28 A-D to therapy delivery module 40 .
  • Separate conductors permit independent selection of individual electrodes 28 A-D.
  • each of the conductors electrically coupled to separate electrodes 28 A-D are electrically insulated from each other.
  • Insulating layer 76 surrounds conductors 74 in order to electrically insulate conductors 74 from subcutaneous tissue 66 when lead 14 is implanted in patient 20 and to help protect a clinician who may be handling lead 14 from shock.
  • each of fixation elements 50 , 52 or 54 may be directly coupled to lead body 48 , as shown in FIG. 3B , or indirectly coupled to lead body 48 (e.g., carried by a fixation sleeve).
  • fixation elements 50 , 52 or 54 are each attached to lead body 48 with an adhesive.
  • adhesive 78 is disposed between fixation element 54 and lead body 48 .
  • fixation elements 50 and 54 extend from lead body 48 substantially parallel to epidermis layer 62 , while fixation element 52 extends away from epidermis layer 62 .
  • Implanting lead 14 within subcutaneous tissue 66 such that one or more fixation elements 50 , 52 or 54 extended through dermis layer 64 or even epidermis layer 66 may increase discomfort to patient 20 .
  • one or more fixation elements 50 , 52 or 54 may be visible (e.g., a protrusion may be seen protruding into epidermis 62 ).
  • Discomfort to patient 20 may be attributable to the one or more fixation elements 50 , 52 or 54 causing stress points at the interface between the one or more fixation elements 50 , 52 or 54 and dermis layer 64 , or even epidermis layer 62 .
  • fixation elements 50 , 52 or 54 may rub against dermis layer 64 and/or even epidermis layer 62 , which may lead to erosion of and possible damage to dermis layer 64 and/or epidermis layer 62 .
  • second outer surface portion 49 B is devoid of fixation elements.
  • second outer surface portion 49 B provides a relatively smooth surface for interfacing with epidermis layer 62 or dermis layer 64 .
  • second outer surface portion 49 B may include structural fixation elements that also engage with surrounding tissue to prevent migration of lead 14 . However, these fixation elements do not extend as far from second outer surface portion 49 B as fixation elements 50 , 52 or 54 extend from first portion 49 A in order to minimize the extent to which the fixation elements on second portion 49 B engage with epidermis layer 62 or dermis layer 64 .
  • FIG. 4A is a schematic cross-sectional view of lead 55 including fixation element 56 extending from second outer surface portion 49 B of lead body 48 . As FIG. 4A illustrates, fixation element 56 is relatively small compared to fixation elements 50 , 52 , and 54 .
  • Fixation element 56 does not extend as far from lead body 48 as fixation elements 50 , 52 , and 54 .
  • fixation element 56 extends a distance A from outer surface 49 of lead body 48
  • fixation element 52 (as well as fixation elements 50 and 54 ) extend a distance B from outer surface 49 of lead body 48
  • Distance B of fixation element 56 may be selected such that fixation element 56 engages with subcutaneous tissue 66 , rather than epidermis layer 62 or dermis layer 64 , when lead 55 is implanted in subcutaneous tissue 66 of patient 20 and oriented such that first outer surface portion 49 A faces away from epidermis layer 66 .
  • FIG. 4A Also shown in FIG. 4A are lines 57 A and 57 B, which are shown to demonstrate that lead body 48 defines four quadrants 58 A-D. Rather than describing the arrangement of fixation elements 50 , 52 , 54 , and 56 about lead body 48 with respect to first and second outer surface portions 49 A and 49 B ( FIG. 3B ), respectively, the arrangement of fixation elements 50 , 52 , 54 , and 56 may also be described with respect to quadrants 58 A-D of lead body 48 . In the embodiment of lead 55 shown in FIG.
  • fixation element 50 extends from first quadrant 58 A of lead body 48
  • fixation element 52 extends from second quadrant 58 B
  • third fixation element 54 extends from third quadrant 58 C
  • fixation element 56 extends from fourth quadrant 58 D.
  • Fixation element 56 extending from fourth quadrant has a smaller cross-sectional profile than fixation elements 50 , 52 , and 54 .
  • Lead body 48 also defines quadrants 58 A-D in each of the schematic cross-sectional views shown in FIGS. 3B , 4 B, 5 B, 6 B, 10 B, and 11 . However, for clarity of illustration and description, quadrants are not labeled in FIGS. 3B , 4 B, 5 B, 6 B, 10 B, and 11 . Each of the leads shown in FIGS. 3B , 4 B, 5 B, 6 B, 10 B, and 11 may be described with respect to quadrants 58 A-D. For example, lead 14 shown in FIG.
  • fixation element 50 extends from first quadrant 58 A of lead body 48
  • fixation element 52 extends from second quadrant 58 B
  • third fixation element 54 extends from third quadrant 58 C
  • fourth quadrant 58 D is devoid of any fixation elements.
  • second outer surface portion 49 B may include a non-structural fixation element, such as a surgical adhesive.
  • FIG. 4B is a schematic cross-sectional view of lead 58 including adhesive layer 59 along second outer surface portion 49 B of lead body 48 , and fixation elements 51 , 52 , and 54 along first outer surface portion 49 A.
  • adhesive layer 59 does not protrude from second portion 49 B of adhesive layer to the extend fixation elements 50 , 52 , and 54 protrude from first portion 49 A.
  • an adhesive may be embedded in second portion 49 B of lead body 48 , rather than being a separate adhesive layer 59 .
  • fixation element if any, carried by second outer surface portion 49 B, it is desirable to minimize the extent to which the fixation element along second outer surface portion 49 B engages with and protrudes into epidermis layer 62 or dermis layer 64 in order to increase the comfort to patient 20 .
  • Adhesive layer 59 may be, for example, surgical adhesive elements disposed on or embedded with second outer surface portion 49 B of lead body 48 .
  • suitable adhesive elements are discussed in commonly assigned U.S. patent application Ser. No. 11/591,443 by Martin T. Gerber, entitled “IMPLANTABLE MEDICAL ELONGATED MEMBER WITH ADHESIVE ELEMENTS” and filed on Oct. 31, 2006, which is hereby incorporated by reference in its entirety.
  • the adhesive properties of adhesive layer 59 may be activated by any suitable means, including exposure to fluids, a certain temperature, or by activating agents.
  • adhesive layer 59 may be separated from surrounding tissue by a sheath until lead 14 reaches a targets stimulation site, at which time a clinician may withdraw the sheath to expose adhesive layer 59 to surrounding tissue, which may activate adhesive layer 59 via moisture, temperature or otherwise.
  • Fixation element 51 of lead 58 is disposed on first outer surface portion 49 A, but extends in a superficial direction toward epidermis 62 when lead 58 is implanted in patient such that first outer surface portion 49 A faces a deep direction. Although fixation element 51 extends toward epidermis 62 , fixation element 51 does not contact epidermis 62 because of its placement on first outer surface portion 49 A. In particular, fixation element 51 does not extend as far demarcation line 69 separating first and second outer surface portions 49 A and 49 B, respectively.
  • a lead may include any suitable number of fixation elements in any suitable arrangement about the lead body.
  • leads including alternate numbers and/or arrangements of fixation elements are shown in FIGS. 5A-13B and described in reference thereto. For clarity of description, like numbered reference numbers designate substantially similar elements throughout FIGS. 2-12 .
  • FIGS. 1-13B the components of the leads, as well as any other components that may be illustrated, are not necessarily drawn to scale. For example, each of the hydrogel fixation members 50 , 52 , and 54 shown in FIGS. 2-4B are not necessarily drawn in correct proportion to the length or diameter of lead body 48 .
  • FIGS. 5A and 5B are a perspective view and schematic cross-sectional view, respectively, of lead 82 , which includes fixation elements 83 , 84 , and 86 disposed between proximal end 48 A and electrodes 28 for fixing lead 82 proximate to target stimulation site 18 .
  • proximal end 48 A of lead body typically includes contacts (not shown in FIG. 5A ), for electrically connecting electrodes 28 of lead 82 with a neurostimulator (e.g., neurostimulator 12 in FIG. 1A ), a lead extension or other medical device.
  • Fixation elements 83 , 84 , and 86 are coupled to first outer surface portion 49 A of outer surface 49 of lead body 48 .
  • first outer surface portion 49 A is shown, while second outer surface portion 49 B faces into the plane of the image of FIG. 5A .
  • line 69 indicates the demarcation between first outer surface portion 49 A and second outer surface portion 49 B.
  • fixation elements 83 and 84 are spaced about angle J with respect to each other about the outer perimeter of lead body 48 , while fixation elements 84 and 86 are spaced about angle K with respect to each other. Angles J and K may, but need not be equal. In contrast to fixation elements 50 , 52 , and 54 of lead 14 ( FIGS. 2-4B ), fixation elements 83 , 84 , and 86 are spaced less than about 90° with respect to each other about first portion 49 A of lead body 48 . For example, angles J and K may each be about 45°.
  • fixation elements 83 , 84 , and 86 extend away from epidermis layer 62 .
  • fixation element 83 , 84 or 86 radially extend from first portion 49 A lead body 48 in a direction that results in fixation element 83 , 84 or 86 that are substantially parallel to epidermis layer 62 , as with fixation elements 50 and 54 of lead 14 ( FIGS. 2-3B ).
  • First outer surface portion 49 A of the lead body 48 of each of leads 14 and 82 both include one set of fixation elements (i.e., a group of fixation elements that substantially share an axial position with respect to lead body 48 ) located proximal to electrodes 28 .
  • a lead may include more than one set of fixation elements, and the fixation elements may be otherwise arranged, such as between electrodes 28 , distal to electrodes 28 , or combinations thereof. Examples of these embodiments are shown in FIGS. 6A-8 .
  • FIGS. 6A and 6B are a perspective view and schematic cross-sectional view of lead 90 , which includes two sets 92 and 94 of fixation elements on first outer surface portion 49 A that are axially displaced from each other with respect to lead body 48 .
  • First set 92 include fixation elements 95 - 97
  • second set 94 includes fixation elements 98 - 102 .
  • the fixation elements 95 - 102 do not overlap.
  • fixation elements 95 - 97 of first set 92 each have different radial locations about first outer surface portion 49 A than fixation elements 98 - 102 of second set 94 . Accordingly, fixation elements 95 - 102 each extend from first outer surface portion 49 A of lead body 48 in different radial directions.
  • first and second sets 92 and 94 of fixation elements are shown proximate to electrode 50 .
  • lead 106 may include first set 108 of fixation elements separated from second set 110 of fixation elements by electrodes 28 .
  • First and second sets 108 and 110 of fixation elements are each disposed along first outer surface portion 49 A of lead body 48 .
  • first and second sets 108 and 110 of fixation elements which may each include any suitable number of fixation elements, may be located proximate and distally, respectively, with respect to electrodes 28 .
  • both leads 14 ( FIGS. 3A-3 ) and 106 include fixation elements for fixing leads 14 and 106 , respectively, to target stimulation site 18 ( FIG.
  • lead 106 may be useful for locally fixing distal end 48 B of lead body 48 .
  • therapy system 10 FIGS. 1 and 2
  • therapy system 10 it may be desirable to locally fix distal end 48 B of lead body 48 .
  • FIG. 8 is a perspective view of yet another embodiment of lead 112 in accordance with the invention.
  • lead 112 includes third set 114 of fixation elements between electrodes 28 B and 28 C.
  • Third set 114 includes fixation elements 116 , 118 , 120 , and 122 .
  • lead 112 may include a set of fixation elements between all of electrodes 28 or between any other combination of electrodes (e.g., between electrodes 28 A and 28 B).
  • each of leads 14 , 82 , 90 , and 106 of FIGS. 3A , 5 A, 6 A, and 7 include fixation elements angled toward proximal end 48 A of lead body 48
  • the fixation elements may also be angled toward distal end 48 B of lead body 48 .
  • fixation elements 116 and 122 of third set 114 of fixation elements of lead 112 shown in FIG. 8 are angled toward proximal end 48 A of lead body 48
  • fixation elements 118 and 120 are angled toward distal end 48 B.
  • Fixation elements 116 , 118 , 120 , and 122 each extend from lead body 48 at an acute angle with respect to first portion 49 A of lead body 48 .
  • fixation elements of a lead in accordance with the invention may also extend radially outward at about 90° with respect to first portion 49 A of lead body 48 .
  • FIG. 9 is a perspective view of lead 124 including fixation elements 126 , 128 , and 130 that extend radially outward at approximately 90° with respect to first outer surface portion 49 A of lead body 48 .
  • FIGS. 10A and 10B are a perspective view and cross-sectional view, respectively, of lead 134 , which includes fixation element 136 that extends around first outer surface portion 49 A of lead body 48 .
  • fixation element 136 is shown in FIGS. 10A and 10B as expanding radially outward without an angular component (i.e. at 90° with respect to first outer surface portion 49 A), in alternate embodiments, fixation element 136 may extend from lead body 48 at an angle with respect to first portion 49 A.
  • fixation element 136 is disposed between electrodes 28 and proximal end 48 A of lead body 48 .
  • lead 134 may include any suitable number of fixation elements that extend around first outer surface portion 49 A of lead body 48 and/or fixation element 134 may be used in combination with tine-like or other fixation members that do not extend around first outer surface portion 49 A of lead body 48 .
  • fixation member 136 may extend around 25%, 50% or 75% of the outer perimeter of first outer surface portion 49 A of lead body 48 .
  • FIG. 11 shows a schematic cross-sectional view of lead 138 , which includes fixation element 140 extending around about 75% of first outer surface portion 49 A of lead body 48 .
  • lead body 48 is cylindrical and defines first outer surface portion 49 A carrying fixation elements, while second outer surface portion 49 B is devoid of any fixation elements or includes one or more fixation elements that do not engage with epidermis 62 ( FIG. 3A ) when lead 14 is implanted in subcutaneous tissue 66 .
  • a lead may include a paddle shape (i.e. a paddle lead) and may include fixation elements along one surface of the paddle lead, to thereby define a paddle lead including interior fixation when the paddle lead is implanted in subcutaneous tissue 66 ( FIG. 2 ) of patient 20 or near occipital region 29 ( FIG. 1 ) of patient 20 .
  • FIGS. 12A and 12B are a side view and a schematic cross-sectional view of paddle lead 142 , respectively, which includes substantially flat, paddle-like shaped lead body 144 coupled to distal end 146 A of lead body connector 146 .
  • a proximal end (not shown in FIG. 12A ) of lead body connector 146 may be mechanically coupled to a neurostimulator (e.g., neurostimulator 12 of FIGS. 1 and 2 ) or another medical device.
  • Lead body 144 defines a “paddle” like shape, including first surface 144 A and second surface 144 B, which is opposite first surface 144 A.
  • FIG. 12B which is a schematic cross-sectional view of lead body 144 taken along line 12 B- 12 B in FIG. 12A
  • lead body 144 defines an outer perimeter 145 (shown in phantom lines).
  • Line 147 demarcates first and second surfaces 144 A and 144 B, respectively, which each extend around about fifty percent of outer perimeter 145 of lead body
  • electrodes 148 are carried by first surface 144 A of lead body 144 .
  • paddle lead 142 may also include electrodes along second surface 144 B of lead body 144 .
  • Each of electrodes 148 may be electrically coupled to the neurostimulator, lead extension or other medical device via electrical conductors disposed within lead body connector 146 .
  • a proximal end (not shown in FIG. 12A ) of lead body connector 146 may include electrical contacts for electrically connecting the electrical conductors within lead body connector 146 with the neurostimulator.
  • First surface 144 A of lead body 144 includes fixation elements 149 A-E, while second surface 144 B is devoid of any fixation elements.
  • fixation elements 149 A-D are tine-like structures that are angled toward lead body connector 146 .
  • fixation elements 149 A-D on first surface 144 A of paddle lead body 144 may be any suitable shape or type of fixation element, and may extend from first surface 144 A at any suitable angle (e.g., radially outward or away from lead body connector 146 ).
  • lead 142 When paddle lead 142 is implanted in patient 20 , lead 142 may be oriented such that first surface 144 A, and accordingly fixation elements 149 A-D, faces away from epidermis 62 , scalp 30 or another integumentary layer of patient 20 in order to help minimize or eliminate any discomfort or irritation to patient attributable to fixation elements 149 A-D.
  • Second surface 144 B of lead body 144 provides a relatively smooth surface for interfacing with epidermis 62 ( FIG. 2 ) or scalp 30 of patient 20 because second surface 144 B does not have any fixation elements that may engage with epidermis 62 or scalp 30 to create points of stress.
  • FIG. 13A is a side view of another embodiment of paddle lead 150 , which includes substantially flat, paddle-like shaped lead body 144 coupled to distal end 146 A of lead body connector 146 and electrodes on first surface 144 A of lead body 144 .
  • lead 150 includes fixation element 152 on second surface 144 B of lead body 144 .
  • fixation element 152 is a layer of surgical adhesive that helps prevent migration of lead 150 following implantation in patient 20 .
  • surgical adhesive layer 152 may be adhesive elements disposed on or embedded with second surface 144 B of lead body, as discussed by commonly assigned U.S.
  • FIG. 13B is a side view of another embodiment of paddle lead 154 , which includes fixation elements 156 A-D along second surface 144 B of lead body 144 .
  • Fixation elements 149 A-D as well as fixation elements 156 A-D may engage with surrounding tissue to help substantially fix a position of lead 154 proximate to target stimulation site 18 .
  • fixation elements 156 A-D are tine-like structures that are angled toward lead body connector 146 .
  • fixation elements 156 A-D on second surface 144 B of paddle lead body 144 may be any suitable shape or type of fixation element (e.g., one or more balloon fixation elements) and may extend from second surface 144 B at any suitable angle (e.g., radially outward or away from lead body connector 146 ).
  • Fixation elements 156 A-D do not extend from second surface 144 B of lead body 144 to the extent that fixation elements 149 A-D extend from first surface 144 A of lead body 144 . That is, in FIG. 13A , dimension E, which is the overall distance each of fixation elements 149 A-D extend from first surface 144 A of lead body 144 is greater than dimension F, which is the overall distance each of fixation elements 156 A-D extend from second surface 144 B. Dimension F is selected such that fixation elements 156 A-D do not engage with and protrude into an integumentary layer (e.g., epidermis layer 62 (and in some cases, dermis layer 64 ) or scalp 30 ( FIG.
  • an integumentary layer e.g., epidermis layer 62 (and in some cases, dermis layer 64 ) or scalp 30 ( FIG.
  • fixation elements 156 A-D may thus help minimize any discomfort to patient 20 that is attributable to fixation elements 156 A-D.
  • FIG. 14 is a flow diagram of process 160 for implanting a lead 14 ( FIGS. 1-3B ) including fixation elements along first surface 49 A of lead body 48 in accordance with the invention. While lead 14 is referenced in the description of FIG. 14 , it should be understood that process 160 may be used to implant any of leads 82 , 90 , 106 , 112 , 124 , 134 , and 138 of FIGS. 5A , 6 A, 7 , 8 , 9 , 10 A, and 11 , respectively, or any other lead including fixation elements disposed along a portion (e.g., first portion 49 A) of an outer surface of lead body 48 in accordance with the invention. Furthermore, while implantation of lead 14 into subcutaneous tissue 66 ( FIG. 3A ) of patient 20 is described, in other embodiments, lead 14 may be implanted proximate to any suitable target therapy delivery site in patient 20 .
  • a lead introducer such as an introducer needle, is introduced into epidermis layer 62 ( FIG. 3A ) of patient 20 ( FIG. 1 ) and a distal end of the introducer is guided into subcutaneous tissue 66 proximate to nerve 68 ( 162 ).
  • the introducer needle may be inserted into the patient percutaneously or via an incision (e.g., incision 33 in FIG. 1 ) in epidermis layer 62 .
  • Lead 14 is introduced into a lumen of the introducer ( 164 ).
  • distal end 14 B of lead 14 is introduced into the lumen before proximal end 14 A.
  • Lead 14 is advanced through the lumen until electrodes 28 adjacent to distal end 48 B of lead body 48 B of lead 14 are positioned proximate to nerve 68 ( 166 ).
  • distal end 14 B of lead 14 may be advanced through the lumen of the introducer until at least distal end 14 B protrudes past the lumen and into tissue of patient 20 and fixation elements 50 , 52 , and 54 are deployed from the introducer (i.e., are advanced past a distal end of the introducer).
  • fixation elements 50 , 52 , and 54 may be deployed from the introducer by withdrawing the introducer or another sheath separating fixation elements 50 , 52 , and 54 from tissue of patient 20 , thereby exposing lead 14 .
  • lead 14 is oriented (e.g., rotated) such that first outer surface portion 49 A of lead body 48 faces away from epidermis layer 62 ( 168 ).
  • Lead 14 may be oriented prior to or subsequent to positioning electrodes 28 proximate to nerve 68 ( 166 ). Positioning of the introducer and/or orientation and positioning of lead 14 may be aided by imaging techniques, such as by fluoroscopy using markers (e.g. radio-opaque or otherwise visible) on lead body 48 . The markers may help indicate a location of fixation elements 50 , 52 , and 54 with respect to the introducer needle. Alternatively, lead 14 may be oriented using visible marker 65 ( FIG.
  • a stylet or introducer 16 may include features (e.g., channels for receiving fixation elements 50 , 52 , and 54 ) for orienting lead 14 such that first outer surface portion 49 A of lead body 48 faces away from epidermis 62 when lead 14 is implanted in patient 20 .
  • fixation elements 50 , 52 , and 54 engage with surrounding subcutaneous tissue 66 to substantially fix electrodes 28 within subcutaneous tissue 66 proximate to nerve 68 .
  • the lead introducer is withdrawn from patient 20 ( 170 ). If an adhesive is also used to help prevent migration of lead 14 after implantation in patient 20 (e.g., an adhesive disposed along second outer surface portion 49 B of lead body 48 ), the adhesive may begin reacting with surrounding tissue or otherwise activating upon deployment into body tissue.
  • a lead comprising one or more fixation elements arranged on lead body 48 to minimize interference with epidermis 62 , scalp 30 or another integumentary layer of patient 20 may include one or more directional electrodes.
  • a “directional” electrode is an electrode that provides electrical stimulation in specific directions, rather than in all directions away from lead body 48 .
  • a directional electrode is an electrode that is exposed around less than the full outer perimeter of the lead body (i.e., circumference in the case of a cylindrical lead body 48 ). An exposed part of an electrode is not electrically insulated or otherwise inhibited from providing electrical stimulation to surrounding tissue when the lead is implanted within patient 20 ( FIG. 1 ).
  • a directional electrode may include one or more exposed sections that together subtend less than about 359° of the outer circumference of lead body 48 in embodiments in which lead body 48 is cylindrical.
  • a directional electrode may include one or more electrode segments (i.e., one or more partial ring electrodes) that define the exposed parts of the electrode.
  • a directional electrode may a full ring electrode that is shielded by an electrically nonconductive (i.e., electrically insulating) material.
  • a directional electrode is any electrode that is configured to provide electrical stimulation in limited directions.
  • Electrodes extending around a portion of the circumference of lead body 48 or along one side of a paddle lead may be useful for providing an electrical stimulation field in a particular direction/targeting a particular therapy delivery site.
  • directing electrical stimulation toward occipital nerves 22 , 24 , and/or 26 , or otherwise away from scalp 30 may be an efficient use of stimulation (as compared to full ring electrodes which would transmit energy toward the occipital nerves and toward the scalp).
  • the increased efficiency may help reduce the overall power delivered to the electrodes of the lead by neurostimulator 12 by eliminating or minimizing the delivery of stimulation to unwanted or unnecessary regions within patient 20 . Reducing the amount of overall power delivered to the electrodes of the lead helps conserve the power (e.g., battery) resources of neurostimulator 12 , which are typically limited.
  • the electrodes may extend around the same portion of outer surface 49 of lead body 48 as the fixation elements. That is, in some embodiments, exposed sections of electrodes reside within first outer surface portion 49 A of lead body 48 , while second outer surface portion 49 B is substantially devoid of any exposed electrodes and in some embodiments, second outer surface portion 49 B is substantially devoid of any electrodes.
  • FIG. 15A is a perspective view of one embodiment of lead 172 including directional electrodes 174 A-D (collectively “electrodes 174 ”), as well as first set 176 of fixation elements and second set 178 of fixation elements along first outer surface portion 49 A of lead body 48 .
  • First and second sets 176 and 178 of fixation elements are located proximally and distally, respectively, to electrodes 174 .
  • electrodes 174 reside between the more proximal first set 176 of fixation elements and the more distal second set 178 of fixation elements.
  • First set 176 of fixation elements comprises fixation elements 180 - 182 and second set 178 includes fixation elements 183 - 185 .
  • Fixation elements 180 - 185 are positioned along first outer surface portion 49 A of lead body 48 .
  • Fixation elements 180 - 182 of first set are substantially axially aligned with each other, while fixation elements 183 - 185 of second set 178 are substantially axially aligned with each other and are axially displaced from first set 176 .
  • fixation elements 180 - 185 within each set 176 , 178 may be axially displaced from each other.
  • second outer surface portion 49 B of lead body 48 is substantially devoid of any fixation elements, e.g., to avoid protrusion of fixation elements into epidermis 62 , scalp 30 or another integumentary layer of patient 20 .
  • second outer surface portion 49 B of lead body 48 may include fixation elements that do not protrude from lead body 48 as far as fixation elements 180 - 185 .
  • FIG. 15B is a schematic cross-sectional end view of lead 172 taken along line 15 B- 15 B in FIG. 15A , where cross-sections of conductors 74 and insulating layer 76 (shown in FIG. 3B ) have been removed from FIG. 15B to simplify the illustration.
  • Directional electrode 174 A is also shown in FIG. 15B .
  • Electrodes 174 A-D are substantially similar, and accordingly, a description of electrode 174 A is also applicable to electrodes 174 B-D.
  • directional electrode 174 A is a partial ring electrode (i.e., a single electrode segment) that extends around less than the full outer perimeter of lead body 48 .
  • Directional electrode 174 A subtends angle L, where angle L may be any angle less than 360°, and in the embodiment shown in FIG. 15B angle L is between about 30° and 270°.
  • angle L may be any angle less than 360°
  • angle L is between about 30° and 270°.
  • the entire directional electrode 174 A is exposed.
  • electrical insulation may cover a part of electrode 174 A to expose a subsection of electrode 174 A, rather than the entire electrode 174 A.
  • An embodiment including electrical insulation covering a part of an electrode is shown in FIGS. 15C and 16 .
  • Electrode 174 A resides within first outer surface portion 49 A of lead body 48 . Electrode 174 A, however, does not span the entire first outer surface portion 49 A, but rather, electrode 174 A extends along substantially the same circumferential subsection occupied by fixation elements 180 - 182 and extends between the outermost (in a circumferential direction) fixation elements 180 and 182 of first set 176 . In this way, the circumferential size of electrode 174 A substantially matches the area of first outer surface portion 49 A occupied by fixation elements 180 - 182 . Second set 178 of fixation elements is substantially symmetrical to first set 176 , and accordingly, electrode 174 A also extends between the outermost fixation elements 183 and 185 of second set 178 .
  • a circumferential size of each electrode 174 may be greater than the circumferential subsection occupied by fixation elements 180 - 182 . That is, each electrode 174 may extend past outermost fixation elements 180 and 182 of first set 176 .
  • a circumferential size of each electrode 174 may be less than the circumferential subsection occupied by fixation elements 180 - 182 . That is, each electrode 174 may not extend completely between outermost fixation elements 180 and 182 of first set 176 .
  • fixation elements 180 - 182 it may be desirable to direct electrical stimulation in the same direction in which fixation elements 180 - 182 extend.
  • lead 172 is implanted in subcutaneous region 66 (shown in FIG. 2 ) of patient 20 , such as in occipital or trigeminal nerve stimulation applications of lead 172 , it may be desirable to direct electrical stimulation in a deep direction as well as implant lead 172 such that fixation elements 180 - 182 extend in a deep direction so as not to irritate or cause damage to epidermis 62 or dermis 64 (shown in FIG. 2 ).
  • electrode 174 A When lead 172 is implanted within patient 20 ( FIG. 1 ) and neurostimulator 12 ( FIG. 1 ) provides electrical stimulation therapy to surrounding tissue via directional electrode 174 A (which may be coupled to neurostimulator 12 via an electrical conductor disposed within lead body 48 ), electrical stimulation is provided in directions radially outward (in the case of a cylindrical lead body 48 ) from first outer surface portion 49 A of lead body 48 because directional electrode 174 A is only located within first outer surface portion 49 A. Because second outer surface portion 49 B is devoid of any electrodes or any exposed electrodes, electrode 174 A is configured to limit stimulation in directions radially outward from first outer surface portion 49 A, and prevent stimulation in directions radially outward from second outer surface portion 49 B.
  • Second outer surface portion 49 B is devoid of any exposed electrodes, and furthermore, second outer surface portion 49 B is devoid of any electrodes in the embodiment of lead 172 shown in FIG. 15B . However, in some embodiments, such as when lead 172 and electrodes 174 deliver electrical stimulation to sacral nerves, it may be desirable for electrodes 174 to also extend at least partially into second outer surface portion 49 B of lead body 48 .
  • FIG. 15C is a schematic cross-sectional view of lead 186 , which is substantially similar to lead 172 , except that lead 186 includes one or more electrodes 188 that are full ring (i.e., a cylindrical) electrodes that each extend around an entire outer perimeter of lead body 48 , rather than electrodes 174 that extend around less than the full outer perimeter of lead body 48 .
  • Full ring electrode 188 subtends about 360° of the outer circumference of lead body 48 .
  • a nonconductive coating 190 may be applied to cover a subsection of electrode 188 .
  • nonconductive coating 190 over at least a subsection of electrode 188 residing within second outer surface portion 49 B results in electrode 188 that includes an exposed portion that resides within first outer surface portion 49 A. In this way, electrical stimulation may be provided in directions limited to those directions radially outward from first outer surface portion 49 A.
  • Nonconductive coating 190 may also be applied to cover a corresponding part of the other electrodes of lead 186 , or the other electrodes may include separate nonconductive coatings to define directional electrodes.
  • Nonconductive coating 190 may be any suitable biocompatible and electrically insulating material, such as, but not limited to, silicone rubber or polyurethane.
  • Nonconductive coating 190 may also be used to electrically insulate a subsection of a partial ring electrode.
  • Nonconductive coating 190 may be any suitable form of electrical insulation that helps block electrical stimulation from electrode 188 .
  • One or more separate (i.e., noncontiguous) electrical insulation pieces may be used to cover a single electrode 188 .
  • one piece may cover a subsection of electrode 188 residing within second outer surface portion 49 B, while another piece may cover a subsection of electrode 188 residing within first outer surface portion 49 A (if a part of electrode 188 within first outer surface portion 49 A is covered).
  • the nonconductive coating 190 may not be a coating, but rather a separate member that is attached to lead body 48 to cover a subsection of one or more electrodes 188 in order to define directional electrodes.
  • the electrically insulating member may be adhered, crimped, or otherwise mechanically held in place relative to lead body 48 .
  • section 188 A of electrode 188 along first outer surface portion 49 A and section of electrode 188 B along second outer surface portion 49 B are masked by coating 190 .
  • coating 190 exposes section 188 C of electrode 188 that substantially “matches” the arrangement of fixation elements 180 - 182 .
  • coating 190 may be applied to only second outer surface portion 49 B to define a directional electrode that includes an exposed section that spans the entire first outer surface portion 49 A or coating 190 may be applied to only a part of second outer surface portion 49 B to define a directional electrode that includes an exposed part (or section) that spans a part of second outer surface portion 49 B.
  • the amount of coating 190 and the electrode area covered by coating 190 may vary depending on the particular application of lead 186 and the desired electrical stimulation field that is to be provided by electrode 188 .
  • Nonconductive coating 190 directs electrical stimulation from ring electrode 188 toward a target stimulation site by masking certain sections of electrode 188 to define one or more exposed electrode sections.
  • lead 186 may be oriented such that coating 190 faces toward scalp 30 and the electrically conductive sections of each electrode 188 faces a deep direction and toward occipital nerves 22 , 24 , 26 or a trigeminal nerve.
  • coating 190 also helps to direction electrical stimulation away from certain sites within the patient, such as sites in which electrical stimulation provides little to no effective therapy or sites in which electrical stimulation may be otherwise undesirable or harmful.
  • FIG. 16A is a perspective view of lead 192 and sheath 194 disposed over full ring electrodes 188 to electrically insulate a subsection of electrodes 174 and expose a subsection of electrodes 188 residing within first outer surface portion 49 A of lead body 48 .
  • FIG. 16B is a schematic cross-sectional view of lead 192 taken along line 16 B- 16 B in FIG. 16A , where first and second sets 176 , 178 of fixation elements have been removed for clarity of illustration.
  • Inner surface 194 A ( FIG. 16B ) of sheath 194 is sized and shaped to receive lead body 48 .
  • Sheath 194 may be secured to lead body 48 using any suitable technique.
  • sheath 194 is friction fit around lead body 48 .
  • Sheath 194 may also be adhered to lead body 48 in addition to or instead of being friction fit around lead body 48 .
  • sheath 194 is a complete ring (in cross-section) and is introduced around lead body 48 from a longitudinal direction (i.e., lead 192 is fed through sheath 194 from proximal end 48 A or distal end 48 B of lead body 48 ).
  • sheath 194 has a partial ring cross-section and may be introduced around lead body 48 from an axial direction or a longitudinal direction.
  • the relative sizes of sheath 194 and lead body 48 are not drawn to any particular scale. It may be desirable to limit a thickness T S (measured between inner surface 194 A and outer surface 194 B) of sheath 194 in order to limit the overall profile of lead 192 . Minimizing the overall profile of lead 192 may generally limit the invasiveness of the implantation of lead 192 in patient 20 .
  • sheath 194 only axially extends across a portion of lead body 48 .
  • sheath 194 may substantially extend from proximal end 48 A to distal end 48 B of lead body 48 , or any other percentage thereof, so long as sheath 194 is substantially aligned with electrodes 188 .
  • Sheath 194 includes an electrically insulating portion 196 and electrically conductive portion 198 .
  • electrically conductive portion 198 is aligned with the subsection of ring electrode 188 that is to be exposed. That is, electrically conductive portion 198 is aligned with sections of ring electrode 188 that provides stimulation in desired directions.
  • electrically insulating portion 196 of sheath 190 is aligned with the sections of electrode 188 that faces directions in which it is desirable to limit stimulation. In FIGS.
  • electrically conductive portion 198 of sheath 194 is aligned with first outer surface portion 49 A of lead body 48 in order to define an electrically exposed section of electrode 188 that substantially resides within first outer surface portion 49 A of lead body 48 .
  • electrically conductive portion 198 of sheath 194 subtends angle L of the outer perimeter of lead body 48 .
  • FIG. 17 is schematic cross-sectional view of another embodiment of a lead 200 , which is similar to lead 172 of FIGS. 15A-B , but includes one or more partial ring electrodes 202 that do not match the arrangement of fixation elements 180 - 182 . That is, electrode 202 extends past outermost fixation elements 180 and 182 of first set 176 . The entire electrode 202 is exposed in the embodiment shown in FIG. 17 .
  • Directional electrode 202 subtends angle M, where angle M may be any angle less than 360°, and in the embodiment shown in FIG. 15B angle M is about 180°. In other embodiments, electrodes 202 may extend up to or slightly past demarcation line 69 between first and second outer surface portions 49 A, 49 B.
  • partial ring electrode 202 defines one electrically conductive section that remains within first outer surface portion 49 A of lead body 48 .
  • an electrically nonconductive coating may be applied to partial ring electrode 202 to define one or more electrically conductive sections.
  • a lead including continuous directional electrodes 174 , 188 , and 202 are shown in the embodiments shown in FIGS. 15A-15C , 16 , and 17
  • a lead may include two or more substantially axially aligned segmented electrodes that define a directional electrode that is substantially noncontinuous over first outer surface portion 49 A of lead body 48 , as shown in FIG. 18 .
  • FIG. 18 is a perspective view of lead 204 , which includes groups 206 - 209 of directional electrode segments, as well as first set 176 of fixation elements and second set 178 of fixation elements along first outer surface portion 49 A of lead body 48 .
  • First and second sets 176 and 178 of fixation elements are located proximally and distally, respectively, to groups 206 - 209 of segmented directional electrodes.
  • Lead 204 is substantially similar to lead 172 shown in FIG. 15A except that lead 204 includes segmented electrodes rather than partial ring electrodes 174 .
  • Each group 206 - 209 comprises two or more segmented electrodes that are substantially axially aligned relative to lead body 48 .
  • Group 206 comprises segmented electrodes 206 A-B
  • group 207 comprises segmented electrodes 207 A-C
  • group 208 comprises segmented electrodes 208 A-B
  • group 209 comprises segmented electrodes 209 A-C.
  • Segmented electrodes 206 A-B, 207 A-C, 208 A-B, and 209 A-C are electrodes that do not extend around the full outer circumference of lead body 48 and may each subtend about 1° to about 359° of the outer circumference of lead body 48 .
  • Segmented electrodes 206 A-B, 207 A-C, 208 A-B, and 209 A-C reside within first outer surface portion 49 A of lead body 48 , while second outer surface portion 49 B of lead body 48 is devoid of any electrodes. Accordingly, all exposed subsections of electrodes 206 A-B, 207 A-C, 208 A-B, and 209 A-C are located within first outer surface portion 49 A of lead body 48 .
  • Each segmented electrode 206 A-B, 207 A-C, 208 A-B, and 209 A-C may be electrically coupled to a separate electrical conductor, which electrically couples the respective segmented electrode 206 A-B, 207 A-C, 208 A-B, and 209 A-C to neurostimulator 12 ( FIGS. 1 and 2 ).
  • a switch matrix disposed within neurostimulator 12 may be used to select various segmented electrode 206 A-B, 207 A-C, 208 A-B, and 209 A-C with which to deliver stimulation signals to patient 20 ( FIG. 1 ).
  • the electrode segments may be selected individually or in various combinations to form a wide variety of unipolar, bipolar, and multipolar electrode combinations over a variety of spatial positions and patterns.
  • segmented electrodes are useful for achieving targeted stimulation and may also provide an efficient use of stimulation energy.
  • occipital nerve or trigeminal nerve stimulation it may be desirable to stimulate on only one side of lead body 48 while avoiding stimulation on the other side.
  • it may be useful to include multiple electrode segments within each group 206 - 209 i.e., multiple electrodes that share an axial position), where each electrode segment extends less than 360° of the outer circumference of lead body 48 (e.g., 30, 60, 90 or 120 degrees).
  • segmented electrodes to define multiple “columns” (extending in an axial direction) and “rows” (extending in a circumferential direction substantially perpendicular to the columns) shown in FIG. 18 may be useful for achieving different electrical fields by activating different combinations of electrode segments 206 A-B, 207 A-C, 208 A-B, and 209 A-C.
  • FIG. 18 the arrangement of segmented electrodes to define multiple “columns” (extending in an axial direction) and “rows” (extending in a circumferential direction substantially perpendicular to the columns) shown in FIG. 18 may be useful for achieving different electrical fields by activating different combinations of electrode segments 206 A-B, 207 A-C, 208 A-B, and 209 A-C.
  • FIG. 18 may be useful for achieving different electrical fields by activating different combinations of electrode segments 206 A-B, 207 A-C, 208 A-B, and 209 A-C.
  • electrodes 206 A and 208 A are circumferentially aligned to define a column
  • electrodes 207 A and 209 A are circumferentially aligned to define another column
  • electrodes 207 B and 209 B are circumferentially aligned to define yet another column, and so forth, while each group 206 - 209 defines a separate row of electrodes.
  • FIG. 19A is a perspective view of lead 210 including fixation elements 212 , 213 , and 214 proximal to directional electrodes 216 A-D.
  • FIG. 19B is a cross-sectional view of lead 210 taken along line 19 B- 19 B in FIG. 19A .
  • Lead 210 is an embodiment of a lead including electrodes 216 A-D that are each electrically conductive along the entire first outer surface portion 49 A of lead body 48 .
  • electrode 216 A (which is representative of each of electrodes 216 A-D) is exposed along first outer surface portion 49 A from fixation element 98 to opposing fixation element 102 .
  • Electrodes 216 A-D may be each any suitable electrode that includes an exposed section that is isolated on first outer surface portion 49 A of lead body 48 .
  • electrodes 216 A-D may each be partial ring (or segmented) electrodes (as shown in FIG. 15A-B , 17 or 18 ) or full ring electrodes covered by electrical insulation along at least second outer surface portion 49 B (as shown in FIGS. 15C and 16 ).
  • a lead including a one or more fixation elements along an interior surface may be useful for various electrical stimulation systems.
  • the lead may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, dystonia, torticollis, epilepsy, pelvic floor disorders, gastroparesis, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles) or obesity.
  • FES functional electrical stimulation
  • fixation element arrangement described herein with respect to leads 14 , 82 , 90 , 106 , 112 , 124 , 134 , and 138 may also be useful for fixing a catheter, such as a drug deliver catheter, proximate to a target drug delivery site.

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US11/706,146 US7684873B2 (en) 2006-10-31 2007-02-14 Implantable medical lead including a directional electrode and fixation elements along an interior surface
PCT/US2007/082819 WO2008055097A2 (fr) 2006-10-31 2007-10-29 Fil médical implantable incluant une électrode directionnelle et des éléments de fixation le long d'une surface intérieure
EP07863603A EP2086629A2 (fr) 2006-10-31 2007-10-29 Fil médical implantable incluant une électrode directionnelle et des éléments de fixation le long d'une surface intérieure
PCT/US2008/053543 WO2008100841A1 (fr) 2007-02-14 2008-02-11 Dérivation médicale implantable comportant une électrode directionnelle et des éléments de fixation le long d'une surface intérieure

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US11/591,279 US8688238B2 (en) 2006-10-31 2006-10-31 Implantable medical elongated member including fixation elements along an interior surface
US11/706,146 US7684873B2 (en) 2006-10-31 2007-02-14 Implantable medical lead including a directional electrode and fixation elements along an interior surface

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US20110190858A1 (en) * 2010-01-29 2011-08-04 Medtronic, Inc. Lead having expandable distal portion
US20110190785A1 (en) * 2010-01-29 2011-08-04 Medtronic, Inc. Introduction of medical lead into patient
US20110190857A1 (en) * 2010-01-29 2011-08-04 Medtronic, Inc. Anchor assembly for use in occipital nerve stimulation
US20120017923A1 (en) * 2010-07-26 2012-01-26 Lior Sobe Removable Navigation System and Method for a Medical Device
US20120029590A1 (en) * 2010-03-24 2012-02-02 Khosrow Daneshvar Method and means to adjust the positioning of stimulating neural and muscular electrode
US8649879B2 (en) 2011-02-08 2014-02-11 Boston Scientific Neuromodulation Corporation Leads with retention features for segmented electrodes and methods of making and using the leads
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